Solcoseryl 42,5mg/ml solution for i/m and i/v injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

hemodialysate from calves blood protein-free

Available from:

Legacy Pharmaceuticals Switzerland GmbH

ATC code:

առկա չէ (B05ZA)

INN (International Name):

hemodialysate from calves blood protein-free

Dosage:

42,5mg/ml

Pharmaceutical form:

solution for i/m and i/v injection

Units in package:

(25/5x5/) ampoules 2ml, blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-03-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SOLCOSERYL® Injection Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION
_Active ingredient:_
Protein free haemodialysate of calf blood (_Bos taurus_), chemically
and
biologically standardized
_Excipients:_
Hydrochloric acid 25%, Sodium hydroxide 27%, Water for injections pro
1 ml.
3. GALENIC FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
1 ml of Solcoseryl Injection Solution (_i.v._) contains 42.5 mg
protein free haemodialysate of
calf blood (_Bos taurus_), chemically and biologically standardised
1 ampoule of 2 ml contains 85 mg protein free haemodialysate of calf
blood, chemically and
biologically standardised
1 ampoule of 5 ml contains 212.5 mg protein free haemodialysate of
calf blood, chemically
and biologically standardised
4. CLINICAL PARTICULARS
4.1 INDICATIONS AND USAGE
Peripheral arterial occlusive disease (PAOD) in stages III/IV in
patients with
contraindications for or intolerance of other vasoactive drugs;
Chronic venous insufficiency with therapy resistant leg ulcers
4.2 DOSAGE AND ADMINISTRATION
If appropriate to the clinical condition of the patient, it is
recommended that Solcoseryl is
administered as an intravenous infusion whenever possible and not as
an intravenous
injection. Solcoseryl Injection Solution must not be administered as a
bolus injection.
When administered as an infusion or an injection, Solcoseryl Injection
Solution should be
diluted in a ratio of at least 1:1 with a sodium chloride or glucose
solution or with a mixed
glucose/sodium chloride solution and administered slowly. Solcoseryl
Injection Solution
should not be diluted with potassium containing infusion solutions.
Infusion:
Whenever possible, Solcoseryl should be administered as an intravenous
infusion, in
particular if the total volume of the diluted solution is more than 40
ml. The speed of
the infusion depends on the patient's haemodynamic status.
Injection:
If administration of Solcoseryl as an injection is unavoidable, the
solution sho